【摘要】 目的:系统评价曲拉西利在广泛期小细胞肺癌(extensive stage small cell lung cancer, ES-SCLC)中预防化疗所致骨髓抑制(chemotherapy-induced myelosuppression, CIM)的有效性、安全性、经济性和抗肿瘤疗效，为临床合理用药提供循证证据。方法:系统检索PubMed、Embase、CENTRAL、CNKI、WanFang Data和SinoMed中英文数据库，纳入ES-SCLC在化疗前使用曲拉西利或安慰剂预防CIM相关的随机对照试验(randomized controlled trials, RCT)与经济学研究，检索时限从建库至2024年8月31日。按照纳入与排除标准独立筛选文献、提取资料并评价纳入文献的偏倚风险，进行描述性分析或采用RevMan 5.4软件进行Meta分析。结果:共纳入4篇RCTs, 327例患者，具有中等偏倚风险。Meta分析结果显示，有效性方面，曲拉西利组的严重中性粒细胞减少症[相对危险度(risk ratio, RR)=0.18,95%CI(0.05,0.63),P=0.008]、中性粒细胞减少症伴发热[RR=0.27,95%CI(0.10,0.71),P=0.008]、白细胞减少症[RR=0.34,95%CI(0.17,0.67),P=0.002]、贫血[RR=0.68,95%CI(0.57,0.82),P<0.000 1]的发生率均低于安慰剂组；严重中性粒细胞减少症的持续时间[均数差(mean difference, MD)=-3.23,95%CI(-4.38,-2.07),P<0.000 01]较安慰剂组更短；红细胞生成刺激剂(erythropoiesis-stimulating agent, ESA)使用率[RR=0.49,95%CI(0.25,0.97),P=0.04]和治疗5周及以后的红细胞输注率[RR=0.59,95%CI(0.36,0.95),P=0.03]较安慰剂组显著下降。安全性方面，两组全因死亡率和不同不良事件种类发生率的差异均无统计学意义(P>0.05)。抗肿瘤疗效方面，两组客观缓解率、无病进展生存期和总生存期的差异无统计学意义(P>0.05)。经济性方面，共纳入4篇研究，国外数据表明曲拉西利具有成本-效益。结论:ES-SCLC患者化疗前使用曲拉西利可以有效降低CIM的发生，减少ESA和红细胞输注等支持治疗，安全性良好，并可降低患者的经济负担，但对生存期无显著影响。未来仍需高质量研究进一步评估其对长期生存结局的获益。更多还原

【Abstract】 Objective: To systematically review the effectiveness, safety, anti-tumor efficacy, and cost-effectiveness of trilaciclib in preventing chemotherapy-induced myelosuppression(CIM) in extensive stage small cell lung cancer(ES-SCLC), providing evidence-based support for rational drug use in clinical practice. Methods: Databases of PubMed, Embase, CENTRAL, CNKI, WangFang Data, and SinoMed were systematically searched. Randomized controlled trials(RCT) and economics research of preventing CIM with the use of trilaciclib or placebo prior to chemotherapy up to August 2024 were included. Reviewers screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the risk bias of included studies. Then descriptive analysis or Meta-analysis was conducted using the RevMan 5.4 software. Results: A total of four RCTs involving 327 patients were included. Risk bias assessment results showed moderate bias. The Meta-analysis results showed that in terms of effectiveness, the incidence of severe neutropenia [RR=0.18, 95%CI(0.05, 0.63), P=0.008], neutropenia with fever [RR=0.27, 95%CI(0.10, 0.71), P=0.008], leukopenia [RR=0.34, 95%CI(0.17, 0.67), P=0.002], anemia [RR=0.68, 95%CI(0.57, 0.82),P<0.000 1] in the trilaciclib group were superior to the placebo group. The duration of severe neutropenia [MD=-3.23, 95%CI(-4.38,-2.07), P<0.000 01] was shorter than the placebo group. The utilization rate of erythropoiesis-stimulating agent(ESA) [RR=0.49, 95%CI(0.25, 0.97), P=0.04] and the transfusion rate of red blood cells after 5 weeks of treatment [RR=0.59, 95%CI(0.36, 0.95), P=0.03] were significantly lower in the trilaciclib group. In terms of safety, there was no statistically significant difference in the incidence of all-cause mortality and different types of AEs between the two groups(P>0.05). In terms of anti-tumor efficacy, there was no significant difference in objective response rate, progression free survival, and overall survival between the two groups(P>0.05). In terms of economics, a total of four studies were included, and foreign data showed that trilaciclib was cost-effective. Conclusion: The use of trilaciclib before chemotherapy in ES-SCLC patients can effectively reduce the occurrence of CIM, reduce supportive treatments such as ESA and red blood cell transfusion, with good safety, no significant impact on survival, and can reduce the economic burden on patients. High quality research is still needed in the future to further evaluate the long-term survival outcomes.更多还原